Better Patient Selection to Transcatheter Aortic Valve Implantation

University of Oslo (UIO)

Status: Completed

Conditions: Aortic Valve Stenosis; Myocardial Fibrosis; Left Ventricular Dysfunction

Treatments: Diagnostic Test: Dobutamine stress test

Study type: Observational

Funder types: Other

Identifiers

NCT03107923

535444

Details and patient eligibility

About

This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Full description

In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

Enrollment: 103 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.

Exclusion criteria

• Aortic valve endocarditis
• aortic annulus >31mm
• preoperative pacemaker
• severe aortic insufficiency (>grad 3)
• rapid atrial fibrillation
• unprotected left main coronary stenosis not suitable for percutaneous intervention.
• unstable angina
• life expectancy less than 12 months
• mental disorder including dementia and condition which interferes with protocol compliance.
• renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
• Patients with metal not suitable for MRI.

Trial design

103 participants in 1 patient group

Preoperative myocardial reserve yes/no

Description:

Patients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test.

Treatment:

Diagnostic Test: Dobutamine stress test